Guilty verdict for Theranos founder Elizabeth Holmes, but rapid blood testing still a hot sector on the ASX
Health & Biotech
Health & Biotech
Former Theranos CEO and founder Elizabeth Holmes has been convicted on four counts of fraud and conspiracy by a Northern California District Court jury.
The jury found that that Holmes duped investors and patients by making fabricated claims about Theranos technology that she hailed as a medical breakthrough.
Once a celebrated Silicon Valley entrepreneur, Holmes repeatedly claimed that Theranos’ blood testing device could scan for hundreds of diseases with only a few drops of blood taken with a finger prick.
The fraud was exposed in 2015 and 2016 through stories in The Wall Street Journal written by investigative journalist, John Carreyrou.
Before the stories broke out, Holmes had managed to lure in many influential investors including Rupert Murdoch, Tim Draper, and even former politician Henry Kissinger – and in the process amassing a paper fortune of $US4.5 billion.
She now faces a possible jail term of 20 years, with her former COO Ramesh Balwani also facing a verdict in the near future.
Rapid blood testing procedure is an easy-to-use test that provides quick results, usually in 20 minutes or less.
Unlike most standard tests, which have to be sent to a lab, rapid tests can provide results at the point of care, which could include a clinic or even your own home.
But they’re most often only used to diagnose infectious diseases, including flu, malaria, HIV, and most recently COVID-19.
In contrast, Theranos claimed that it could perform a large number of tests with a few drops of blood, such as measuring hormone levels, antibodies, and certain cancer markers. In fact its testing “menu” had once offered more than 240 tests on various diseases.
Generally speaking, rapid blood testing is an area of medical technology that’s expected to grow even larger in the coming years.
The market is forecast to grow to US$18bn by 2028, and on the ASX, some companies are already riding on this wave.
The company was founded in Melbourne in 2015, and is still headquartered there, but has manufacturing facilities in California and Florida.
Lumos’ products include FebriDx, which is a finger-prick blood test that can indicate if a person has a general bacterial or viral acute respiratory infection within 10 minutes.
The ViraDx test meanwhile, is a 15-minute three-in-one COVID-19/Flu A/Flu B rapid antigen test for use by qualified healthcare professionals.
“Our technology is designed as sort of a broad spectrum diagnostic test – the idea is it detects the host’s immune response so it works across a wide variety of diseases,” executive chair Sam Lanyon told Stockhead earlier this year.
The company has applied to the FDA for the tests to be approved and if granted, it will be permitted to sell it in the USA and potentially an easy pathway for approval in certain other jurisdictions too.
The FDA decision is expected some time in 2022.
A similar company is Atomo Diagnostics, manufacturer of rapid tests for HIV/AIDs as well as COVID-19.
It listed in April 2020 soon after COVID-19 first broke out, and nearly doubled on debut but has retreated since.
In the last six months, the Atomo shares are once again up more than 50%, since its COVID-19 rapid antibody and antigen tests were added by the TGA to the ARTG (Australian Register of Therapeutic Goods).
After selling less than 5,000 units in all of FY21, the company sold 100,000 units in the September quarter alone.
Apart from Lumos and Atomo, there are also the non-rapid blood testing device companies, which means that test result would still need to go to the lab for assessment.
The company is currently seeking a US FDA approval for a “kit” version of its predictive diagnostic blood test for diabetic kidney disease.
A recent study showed the PromarkerD predictive test can improve clinical outcomes for patients with type 2 diabetes.
It’s a simple blood test that can predict future kidney function decline in patients with type 2 diabetes.
The company says that its biomarker-based test can also predict a decline in renal function up to four years in advance.
The company says its bowel cancer biomarker product, ColoSTAT, could potentially be extended to five more cancer detections including: breast, cervical, lungs, gastric, and pancreatic.
In September, the company enlisted 815 patients across 11 Australian sites for its clinical trial on coloSTAT, a low-cost, simple blood test to early detect colorectal cancer, which the company is aiming for mass-market screening.
The final clinical report for this clinical trial is targeted for completion in the first half of 2022, and is a key component for the TGA registration package.
Colorectal cancer is the third biggest cause of cancer-related deaths globally, with more than 935,000 people die from the disease world-wide annually.